Device and draping method for facilitating introduction of a non-sterile container into a sterile environment

Abstract

An improved device for enabling a non-sterile container of liquid, such as, for example, a bottle to be introduced into a sterile environment. In one embodiment, the device seals the non-sterile container within a drape so that the non-sterile container can be introduced into the sterile environment. The device may include a drape having an interior cavity for receiving the non-sterile container and a cap coupled to the enclosure for coupling to the non-sterile container so that the liquid product may flow through the sterile cap.

What is claimed is: 
     
       1. A device for enclosing a non-sterile container to enable introduction of the container into a sterile environment, the device comprising:
 a drape having an interior cavity for receiving a non-sterile container therein creating a sterile barrier; and 
 a cap coupled to the drape, the cap having a first end configured to couple to the non-sterile container and a second end with a nozzle extending through the drape and across the sterile barrier, such that a liquid within the non-sterile container can be expelled through the nozzle of the cap. 
 
     
     
       2. The device of  claim 1 , wherein the drape includes a first end and a second end, the interior cavity extending from the first end to the second end. 
     
     
       3. The device of  claim 2 , wherein the first end of the drape includes an opening for receiving the non-sterile container. 
     
     
       4. The device of  claim 3 , wherein the first end of the drape further comprises a sealing mechanism for sealing the opening when the non-sterile container is positioned within the interior cavity. 
     
     
       5. The device of  claim 4 , wherein the sealing mechanism comprises an adhesive strip. 
     
     
       6. The device of  claim 2 , wherein the nozzle has a first end, a second end, and a thru-bore extending from the first end to the second end. 
     
     
       7. The device of  claim 6 , wherein the second end of the drape is sealed to the cap so that the first end of the cap is positioned within the interior cavity of the drape and the nozzle extends through an opening in the drape so that the second end of the cap is positioned outside of the drape. 
     
     
       8. The device of  claim 7 , wherein the first end of the cap includes a container coupling mechanism for engaging the non-sterile container positioned within the interior cavity of the drape. 
     
     
       9. The device of  claim 8 , wherein the container coupling mechanism is in the form of a threaded cap, a rubber stopper, or a press-fit cap. 
     
     
       10. The device of  claim 8 , wherein the first end of the cap includes a seal piercing mechanism so that, in use, coupling the cap to the non-sterile container causes the seal piercing mechanism to pierce a seal located on the non-sterile container to place the cap in fluid communication with the liquid located within the non-sterile container. 
     
     
       11. The device of  claim 6 , further comprising a splash guard for coupling to the cap. 
     
     
       12. The device of  claim 11 , wherein the splash guard includes an opening for receiving the nozzle of the cap. 
     
     
       13. The device of  claim 12 , wherein the nozzle includes a ridge, the splash guard engageable with the ridge when the splash guard is pressed toward the first end of the cap. 
     
     
       14. A method for introducing a non-sterile container containing a sterile liquid into a sterile environment, the method comprising:
 inserting a non-sterile container into an interior cavity of a sterile cap and drape device; 
 sealing the cap and drape device about the non-sterile container to seal the non-sterile container within the interior cavity of the cap and drape device creating a sterile barrier; 
 coupling a cap to the non-sterile container the cap having a first end configured to couple to the non-sterile container and a second end with a nozzle extending through the drape and across the sterile barrier; and 
 via the cap, dispensing the sterile liquid through the nozzle of the cap within the sterile environment. 
 
     
     
       15. The method of  claim 14 , further comprising coupling a splash guard to the cap by pressing the splash guard into engagement with a nozzle of the cap, the splash guard having an opening for receiving the nozzle therethrough, the nozzle having a ridge for seating the splash guard thereon. 
     
     
       16. The method of  claim 14 , wherein coupling the cap to the non-sterile container comprises coupling a container coupling mechanism formed on a first end of the cap to the non-sterile container. 
     
     
       17. The method of  claim 16 , further comprising adhering an inner surface of the cap and drape device to an outer surface of the non-sterile container. 
     
     
       18. The method of  claim 14 , further comprising adhering an inner surface of the cap and drape device to the non-sterile container. 
     
     
       19. The method of  claim 14 , wherein sealing the cap and drape device about the non-sterile container comprises adhering a portion of the cap and drape device to itself. 
     
     
       20. The method of  claim 19 , wherein adhering a portion of the cap and drape device to itself comprises removing a tape strip adhesive strip disposed on a flap portion of a first end of the drape, and pressing the adhesive strip and flap portion against an outer surface of the cap and drape device.